Risk Checklist

Documentation Essentials

Front page of the Documentation Essentials Checklist

Documentation serves many purposes, from patient care record keeping, to communications, to coding and billing, and even data for quality improvement. It may also preserve information that is critical to the defense of a legal action.

Download our Documentation Essentials Checklist to help review important risk management strategies for documentation and identify potential areas for improvement.

This document should not be construed as medical or legal advice. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions. 

MedPro Group is the marketing name used to refer to the insurance operations of The Medical Protective Company, Princeton Insurance Company, PLICO, Inc. and MedPro RRG Risk Retention Group. All insurance products are underwritten and administered by these and other Berkshire Hathaway affiliates, including National Fire & Marine Insurance Company. Product availability is based upon business and/or regulatory approval and/or may differ among companies. © 2020 MedPro Group Inc. All rights reserved.

Risk Checklist

Due Diligence of Business Associates

Front page of the Due Diligence of Business Associates Checklist

In the current complex healthcare environment, it is increasingly common for healthcare organizations to partner with external businesses. Due diligence screening can help ensure that these Business Associates adhere to a set of standards.

Download our Checklist for Due Diligence of Business Associates to help evaluate your processes.

This document should not be construed as medical or legal advice. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions. 

MedPro Group is the marketing name used to refer to the insurance operations of The Medical Protective Company, Princeton Insurance Company, PLICO, Inc. and MedPro RRG Risk Retention Group. All insurance products are underwritten and administered by these and other Berkshire Hathaway affiliates, including National Fire & Marine Insurance Company. Product availability is based upon business and/or regulatory approval and/or may differ among companies. © 2020 MedPro Group Inc. All rights reserved.

Risk Q&A

Payment Issues in Healthcare Practices

Question
At the time of an appointment, or as a condition of scheduling an appointment, can a healthcare practice require a patient to pay his/her portion of an expected deductible, copayment, or other charge not covered by insurance? If the patient does not pay, can the appointment be cancelled or rescheduled upon receipt of the patient’s payment?

Answer
Patients are obligated to pay for services they receive from healthcare practices, and clinicians are obligated to provide a reasonable standard of care for existing patients and patients for whom contracts or regulations trigger an obligation (e.g., EMTALA referrals, insurance plan contracts, hospital bylaws, etc.).

Balancing business and clinical obligations requires a fact-specific approach. A healthcare practice’s payment expectations and consequences for nonpayment should be included in written policies and procedures as well as patient informational materials.

Before making scheduling decisions (e.g., cancellation or rescheduling) based on a patient’s ability to pay, the healthcare provider should confirm that the scheduling decision will not adversely affect the patient’s health. Additionally, healthcare administrators should determine whether regulations or contractual agreements affect the decision.

Fact variations may include the following related to payment at time of service:

Documentation
If a scheduling decision requires a healthcare provider’s evaluation, then the provider should document his/her clinical assessment and scheduling recommendations in the patient’s health record. For example, the provider might document that because the patient is stable, rescheduling the appointment will not adversely affect his/her health.

Answer

This document should not be construed as medical or legal advice. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions. 

MedPro Group is the marketing name used to refer to the insurance operations of The Medical Protective Company, Princeton Insurance Company, PLICO, Inc. and MedPro RRG Risk Retention Group. All insurance products are underwritten and administered by these and other Berkshire Hathaway affiliates, including National Fire & Marine Insurance Company. Product availability is based upon business and/or regulatory approval and/or may differ among companies. © 2020 MedPro Group Inc. All rights reserved.

Keep It Simple: Using Plain Language to Support Patient-Centered Care

Laura M. Cascella, MA, CPHRM

A significant hurdle in patient-centered care is effective communication throughout the care process. If patients do not understand their diagnoses, test results, recommended treatment plans, and follow-up instructions, they cannot fully participate in their care.

A common barrier to effective communication is poor health literacy. Research shows that only a small percentage of adults have proficient health literacy skills, and most adults have difficulty using the everyday health information that is routinely available in healthcare facilities.1 These statistics are significant because people who have low health literacy are at increased risk for poor outcomes, higher rates of emergency department visits and hospitalization, and death.2 Patients who have limited health literacy also might feel ashamed about their lack of knowledge, and they may “mask these difficulties in order to maintain dignity.”3

Healthcare providers need various tools and techniques to improve communication with patients and develop “standards of practice that support and incorporate health literacy principles . . .”4 One important tool for tackling literacy barriers and improving patient comprehension is plain language. The principles of plain language focus on written information that is clear, concise, and logically organized. Readers should be able to find what they need, understand what they find, and use what they find to meet their needs.5

Because print and online written materials — such as patient education brochures, informational websites, provider instructions, and medical forms — play a vital role in the healthcare process, assessing the quality, readability, and usability of this information is crucial. The following strategies — compiled from various sources6 — offer guidance related to content, text, design and layout, and visuals. This information can help organizations and providers determine whether current or prospective materials align with plain language principles and support efforts to ensure patient comprehension and patient-centered care.

Content

Content refers to the focus, core message, and organization of written information. When assessing content, consider the following questions:

  • Is the purpose and intention of the material clear based on the title and introductory information? Will the reader understand what the information is about and how he/she should use it from an initial glance?

  • Is the content accurate and current? Misinformation about medical conditions and treatments is not uncommon, particularly with the explosion of online information. Healthcare organizations and providers should ensure their information reflects current knowledge and standards.

  • Is the content appropriate for the age and culture of the target audience? Cultural competency goes beyond just language; healthcare providers should consider how cultural beliefs, knowledge, and values might affect patients’ understanding of health information.

  • Does the content focus on what the reader needs and wants to know? Does it avoid using extraneous details and distracting information (e.g., complex descriptions of disease processes)?

  • Is the most important information presented prominently (e.g., at the beginning or using a visual cue that draws attention)? Readers might skim information, so the main messages should be obvious.

  • Does the content contain one or more calls to action? For example, a call to action might prompt the reader to have a health screening or follow up with a healthcare provider.

  • Are important concepts repeated within the material? Repetition can help the reader retain information.

  • Is information presented in a logical order? For example, an informational flyer about a diagnostic test should explain how to prepare for the test before discussing what the results mean.

  • Is similar information grouped together, and does material use descriptive headings and subheadings to help readers navigate the content?

  • Does the material use short paragraphs and focus on one topic per paragraph to avoid overwhelming or distracting the reader? For example, a patient education brochure that discusses asthma treatment should separate information about long-term control medications and quick-relief medications.

  • Does the material use examples and well-designed visuals that make complex material easier to understand? See below for more guidance on visuals.

Text

Text and content are related, but “text” refers to more granular elements such as word choice, sentence length, and tone rather than overall purpose and organization. When evaluating text, consider the following questions:

  • Is the wording at an appropriate reading level for your target audience? Keep in mind that many Americans read at or below an eighth-grade reading level.7 Readability formulas — although not foolproof — can help determine how difficult text is to read. Examples of readability formulas include Fry, SMOG, and Flesch-Kincaid.

  • Is the text conversational in tone and does it favor active voice over passive voice? A conversational tone uses contractions and pronouns and can help forge a connection with the reader. Using active rather than passive voice helps clarify actions and reduce ambiguity. For example, “Call your doctor right away if you have a fever” versus “If a fever develops, your doctor should be notified immediately.”

  • Does the material use words that are well known to individuals without medical training (e.g., “high blood pressure” instead of “hypertension” or “tooth decay” instead of “caries”)? If no common term exists for a medical or technical term, is the term described the first time it is used?

  • Does the text use short sentences? Short sentences help improve readability and avoid information overload; however, sentence length should vary slightly so the text doesn’t sound choppy.

  • Does the text use one- or two-syllable words when possible (e.g., “blood clot” instead of “embolism”)?

  • Are wordy phrases avoided? Although some wordy phrases are common in everyday language, they can still make text less precise and confusing. Examples of wordy phrases include “due to the fact that” (because), “in order to” (to), and “at the present time” (now).

  • Does the text avoid overuse of abbreviations and acronyms, which can distract the reader? If the text includes abbreviations and acronyms, are they defined the first time they are used?

  • Does the text use the same term consistently to identify a specific object or concept? Lack of consistency in terminology can confuse the reader and reinforce inaccurate perceptions.

  • If the text contains numbers, are they presented in a clear, easy-to-understand way, and is their importance explained? Some people might have trouble making sense of ratios, percentages, and fractions. For them, “1 in 8 adults” might be easier to comprehend than 12.5%. Further, without a clear explanation, the reader might not understand if “1 in 8” represents a significant problem or risk.

Design and Layout

The elements of design and layout — such as font style, colors, and spacing — play an important role in the effectiveness of written materials. Even if the content is clear and the text is reader-friendly, poor design and layout can disorient and confuse the reader. When assessing these factors, consider the following questions:

  • Does the material use at least a 12 point font or larger in an easy-to-read typeface? Recommendations generally suggest serif fonts for body text (e.g., Times New Roman) and sans serif fonts for headings (e.g., Arial).

  • Does the material avoid using multiple font styles on the page and throughout the document? Using different fonts to differentiate headings and body text is acceptable, but using a mix of typefaces within the body of a document can create confusion.

  • Does the material use dark font on a light background? Light fonts on dark backgrounds or fonts that do not contrast enough with their backgrounds are hard to see, particularly for people who have vision problems.

  • Is bold or italic typeface used to show emphasis rather than underlining, which is difficult to read and might be confused with hyperlinking? Is the method chosen to show emphasis used sparingly but consistently within the material?

  • Do headings use a mixture of uppercase and lowercase, and are they clearly differentiated from body text (e.g., set in bold)?

  • Is the text aligned to the left margin (including the headings) rather than fully justified (flush with both margins) or centered? Left alignment and a ragged right margin help aid in readability.

  • Does the material use short lists to focus on specific material, highlight information in a visually clear way, or clarify the chronological order of steps in a process? Lists can help break up dense information, making it easier to read and scan. However, long lists and lists with multiple levels (i.e., lists within lists) might be difficult to follow.

  • Does the material use standard bullets (e.g., circles or squares), and is the bullet style consistent throughout the material? To avoid confusion, are numbered lists used to show only items in a sequence?

  • Does the material use white space effectively and consistently, including heading spacing, line spacing, paragraph spacing, and margins? White space can prevent the content from looking too condensed and overwhelming. Plain language and health literacy recommendations suggest:

    • Having at least 1⁄2 inch to 1 inch of white space around the margins of the page and between columns for printed materials.
    • Using more space above headings than below them to help visually link each heading to its related content.
    • Setting line spacing between 1.2 and 1.5 lines.

Visuals

In patient materials, “visuals” can refer to photographs, illustrations, tables, graphs, pictographs, infographics, and more. Well-designed visuals can present or reinforce vital information. When evaluating the visuals in materials, consider the following questions:

  • Do visuals help accurately show or clarify important information, and is their design simple and devoid of clutter and distractions?

  • Do visuals have high-quality resolution and contrast? Although visuals should be simple, they should look professional to enforce the credibility of the material.

  • Are elements such as sidebars, text boxes, and pull-quotes used to emphasize key messages?

  • Does each visual relate to or present only one message? Visual elements that try to present multiple messages might confuse the reader.

  • Are visuals logically located and do they include clear, concise titles and captions?

  • Are visual elements age appropriate and culturally relevant and sensitive?

  • Do visuals that show a process or series of steps have each element numbered to clearly indicate its place in the sequence?

  • Do tables have clearly labeled rows and columns and consistent alignment? Do charts and graphs use descriptive, clear labels and legends?

In Summary

The premise of patient-centered care relies on effective communication that helps patients understand health information and participate in shared decision-making. Yet, inadequate health literacy has been — and continues to be — a persistent communication barrier, hindering patients’ comprehension and marginalizing their role in care.

One important strategy for overcoming health literacy challenges is providing patients with written information in plain language. Materials should be clear, concise, purposeful, logically organized, and well-designed. Incorporating plain language principles as part of an overall strategy to address health literacy can support efforts to engage patients in their care and empower them with knowledge to make informed decisions.

Resources

For more resources about improving verbal and written communication with patients, see MedPro’s Checklist: Strategies to Support Patient Comprehension and Risk Resources: Health Literacy and Cultural Competence.

Endnotes


3 Institute of Medicine, Health literacy: A prescription to end confusion.

This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Communicating Effectively With Patients Who Have Limited English Proficiency

Patient Safety & Risk Solutions

Patients who have limited English proficiency (LEP) often do not understand the health information conveyed to them by healthcare providers. For these patients, inadequate comprehension can result in many negative outcomes, including delayed diagnoses, misunderstanding of care plans, medication errors, lack of follow-through, misuse of health services, and lack of trust and confidence in healthcare providers.1

Because of the far-reaching effects of poor comprehension, healthcare leaders, providers, and staff should proactively identify and address language barriers.

Implementing strategies to improve patient comprehension can help organizations provide optimum care for patients who have LEP and reduce the risk of misunderstandings that could potentially lead to adverse outcomes.

  1. Ask all new patients to indicate their preferred language, and determine whether an interpreter is needed to properly assess language preferences and language assistance needs. Document these preferences in the patient’s health record.

  2. Match patients with qualified bilingual clinicians or staff members, or request an interpreter for patients who do not speak English very well or who appear to have difficulty understanding English.

  3. Display signs in your waiting and reception areas announcing the availability of interpreting services. Note: The Affordable Care Act requires covered entities to post notices of nondiscrimination and taglines that alert individuals who have LEP to the availability of language assistance services.

  4. Use acceptable language assistance services to help your patients who have LEP. Acceptable services include bilingual healthcare providers or staff members, staff trained as interpreters, onsite trained medical interpreters, and telephone or video medical interpreting services.

  5. Do not have healthcare providers or staff who are not trained or certified serve as medical interpreters. Also, for privacy reasons, do not use a patient’s family or friends, including minor children, as interpreters.

  6. Be certain that all healthcare providers, staff, and interpreters use plain language when communicating with patients who have LEP.

  7. Provide written materials in patients’ preferred languages. If unable to do so, secure the assistance of interpreters trained in sight translation. Additionally, obtain multilingual health education materials to distribute to your patients who have LEP to support comprehension and adherence to treatment.

  8. Research whether Medicaid or the Children’s Health Insurance Plan in your state pays for interpreter services. Healthcare providers are reimbursed for providing interpreting services in some states. In others, the state contracts directly with interpreting services.

  9. Contact community organizations to determine whether they can provide volunteer trained medical interpreters.

  10. Consider sharing language interpreting services or developing collaborative contracts with local healthcare organizations to use telephonic or online interpreting services.

  11. Assess your staff’s efforts in meeting language assistance needs. Explore new approaches to address any weaknesses identified.

  12. Routinely conduct a review of the health records of patients who have LEP to ensure that their language assistance needs are being documented and assessed. Ensure that qualified individuals are providing language assistance.

  13. Develop procedures for your office staff to respond to calls from patients who have LEP. If possible, use bilingual office staff or onsite interpreters to respond to these calls.

  14. Reserve blocks of time for patients who have LEP to schedule appointments, and arrange for interpreters to be available during those times.

  15. If your organization provides care to a significant number of patients who have LEP, record answering machine messages in more than one language with prompts. If using an answering service, consider contracting with a service whose language capacity supports your patient population.

Resources

Endnotes


This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Addressing Risks Associated With Telehealth

Patient Safety & Risk Solutions

Advances in telecommunication technologies over the years have increasingly made telehealth a viable option for healthcare delivery. The benefits and value of telehealth have become even more evident in the wake of the COVID-19 pandemic, which rapidly accelerated the adoption of virtual care.


In the current healthcare landscape, telehealth is helping address issues related to healthcare accessibility, cost efficiency, infection prevention, patient satisfaction, and more. Yet, like any type of care, telehealth carries risks, including issues associated with licensing, credentialing and privileging, online prescribing, informed consent, health information privacy and security, standards of care, and care coordination.


Through careful consideration and risk assessment, healthcare organizations and providers can identify safety and liability issues associated with their telehealth services and proactively implement safeguards throughout the telehealth process. The following list offers key strategies for addressing risks associated with telehealth.

  1. Be knowledgeable about federal and state laws and regulations related to telehealth, such as requirements for licensure, online prescribing, informed consent, clinical decision-making, and quality improvement. Check with your state medical, osteopathic, nursing, or dental board for specific guidance.

  2. Verify with your professional liability carrier that you have coverage for the telehealth services you plan to offer.

  3. Identify and implement telehealth best practices, and stay abreast of any changes in telehealth regulations and standards of care. The American Telemedicine Association and other professional associations have published a number of telehealth practice guidelines.

  4. Ensure that providers delivering telehealth services are properly credentialed (either by the originating site or the distant site) and qualified for their proposed scopes of service. Any privileges granted should comply with applicable scope of practice laws.

  5. Develop and implement patient selection criteria and standardized clinical protocols for telehealth services to ensure consistency, quality, and efficiency of care.

  6. When multiple providers are involved in a patient’s care, have a clear understanding of duty of care and clinical responsibilities at both the originating and distant sites, including disclosure of any adverse events. Make sure the specific provisions and accountabilities are documented.

  7. Implement protocols to ensure that communication from distant site telehealth providers is promptly reviewed and necessary actions are taken.

  8. Ensure that technology and equipment used for telehealth services are high quality, functional, and properly maintained and serviced. Providers and staff should be aware of who is responsible for equipment maintenance.

  9. Assess the privacy and security risks of your telehealth systems, and implement safeguards at all points of risk exposure. Monitor the systems for possible security breaches.

  10. Make sure that any telehealth vendors who are considered business associates can demonstrate compliance with applicable laws and regulations. Have legal counsel review all contracts and business associate agreements with vendors.

  11. Train telehealth providers and staff on applicable telecommunication technologies, scope of telehealth services offered, equipment maintenance, and privacy/security standards.

  12. Train telehealth providers and staff on patient care operations and workflow for telehealth encounters (e.g., confirming patient and provider readiness, verifying the patient’s identity, implementing a back-up plan in the event of a technological failure, etc.)

  13. Educate patients about the availability and types of telehealth services, required technology, potential limitations, and situations in which care delivery via telehealth is not optimal or viable.

  14. Conduct thorough informed consent discussions with patients that include information related to the proposed treatment or procedures as well as a discussion of risks specific to the delivery of care using telecommunication technologies.

  15. Develop a written policy related to documentation for telehealth services, and verify that providers and staff members are knowledgeable about and comply with the policy.

  16. Ensure that your organization’s mechanism for incident reporting supports telehealth events, and evaluate telehealth activities as part of ongoing quality improvement initiatives. Surveys or questionnaires can help gauge provider and patient satisfaction with telehealth services.

Resources

For more information about managing risks associated with telehealth, see Risk Resources: Telehealth/Telemedicine and take MedPro’s on-demand continuing education program Telemedicine: Evaluating Virtual Care From a Risk Management Perspective.

This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Managing Nonadherent and Difficult Patients

Patient Safety & Risk Solutions

Healthcare providers face many challenges when patients are nonadherent or difficult. These behaviors can compromise the provider-patient relationship, and patients might be at an increased risk of misdiagnosis and more likely to have negative outcomes.

One study, for example, showed that clinicians were 42 percent more likely to wrongly diagnose a complex medical issue and 6 percent more likely to wrongly diagnose a simple medical issue when dealing with difficult patients.1

To mitigate the challenges that nonadherence presents, healthcare organizations should create a policy that specifically defines a patient’s rights and responsibilities, display it in the organization, and make it available to all patients. This policy will provide the basis on which to build effective provider-patient relationships.

The following strategies offer additional ways to proactively engage nonadherent and difficult patients and address potentially problematic behaviors.

  1. Be aware of the difference between informed refusal of care and patient nonadherence to an agreed-upon treatment plan. A patient can refuse care even if the consequences might be dire.

  2. During each patient encounter, emphasize the importance of following the agreed-on treatment regimen, even if symptoms subside. Explain the possible consequences of not following the prescribed treatment plan.

  3. Provide nonadherent patients with education about their treatment plans both verbally and in writing — especially if a patient has serious health problems.

  4. With patients’ permission, include family members, caretakers, and significant others in education about the importance of following treatment plans. These individuals might help reinforce the importance of adhering to treatment.

  5. Consider that a patient-centered approach seeks to get patients more involved in their care. During patient encounters, ask open-ended, probing, and nonjudgmental questions to identify factors influencing nonadherence.

  6. Try various communication techniques such as motivational interviewing to empower patients to set goals they believe are attainable. Understanding the patients’ stages of changing behavior and dealing with discouragement will support a mutually agreed on care plan.

  7. Use a technique such as teach-back to ensure that patients fully understand the information and instructions provided. Patients from all racial, ethnic, socioeconomic, and educational backgrounds might have limited health literacy, which can contribute to nonadherence.

  8. Consider patients’ lifestyles and medication costs when prescribing. A variety of situational, geographic, economic, and cultural issues can contribute to nonadherence.

  9. If a patient has financial, physical, or emotional limitations that lead to nonadherence, determine whether any community services are available to help the patient overcome treatment barriers.

  10. Consider using patient agreements that detail both provider and patient responsibilities relative to the treatment regimen. Both parties should sign the agreement.

  11. If a patient is missing appointments, try to determine the reason (e.g., transportation, family care, or financial issues). After several missed appointments, consider sending the patient a letter stressing the importance of keeping the appointments and adhering to the treatment plan. Keep a copy of the letter in the patient’s health record.

  12. Document missed or cancelled appointments by noting either “patient no-show” or “cancelled” in the patient’s health record. If possible, document the reason for a cancellation — e.g., “no transportation” or “child care issues.”

  13. Do not delete original appointment entries; the appointment log might become a valuable tool if you have to demonstrate a patient’s continued nonadherence to appointments.

  14. Document a description of all clinical nonadherence in the patient’s health record, as well any education provided to the patient, family, caregiver, and/or significant other regarding the possible consequences of not following the treatment regimen.

  15. When documenting, use subjective statements from the patient or others and objective information obtained through patient encounters. Avoid disparaging remarks or editorializing when documenting information in the health record related to patients’ nonadherent behaviors.

Endnote


This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Addressing Sexual Harassment from Patients or Third Parties

Patient Safety & Risk Solutions

Question

How can my healthcare organization address issues related to sexual harassment and inappropriate
behavior by patients or their family members?

Answer

Sexual harassment and other types of inappropriate behavior from patients and third parties (e.g.,
patients’ family members, friends, or caregivers) is not unusual in healthcare. A Medscape survey
of physicians showed that more than a quarter (27 percent) reported sexual harassment from
patients.1 A separate Medscape poll found that 71 percent of nurses reported patient harassment.2
The types of harassment reported include unwanted touching, sexual comments, inappropriate
texting and emailing, sexual propositions, requests for dates, and more.

Complicating this serious issue is the unique dynamic between patients and healthcare providers,
particularly in situations in which (a) providers are legally or ethically obligated to provide
treatment, or (b) patients’ inappropriate behaviors reflect a medical condition, such as dementia
or a psychotic episode.3 To navigate this complex dilemma, healthcare organizations should
proactively plan for harassment scenarios. Consider the following strategies:

  • Ensure your organization’s harassment policies include information and procedures related to harassment from patients and third parties.

  • Support a culture of safety and well-being that encourages individuals to report all instances of harassment they experience or witness. Make employees aware that their safety is a top priority.

  • Empower healthcare providers and other staff members to say “no” and voice their discomfort if patients or other third parties act inappropriately.

  • Develop incident response procedures for handling reports of sexual harassment, and ensure employees understand the process for reporting incidents. Incident procedures might include:

    • Having a designated individual talk with the patient or third party about his/her behavior or actions.
    • Requiring additional providers or staff members to be present during interactions with the harassing patient or third party.
    • Reassigning the patient to other providers or staff members (e.g., reassigning a male patient to a male nurse if a female nurse is being harassed).
    • Restricting the patient’s access to certain areas within the facility and/or closely monitoring the patient’s behavior.
    • Advising the patient to find another source of care or terminating the provider–patient relationship. (Note: This strategy is not applicable in all situations or care settings.)
    • Contacting law enforcement in cases resulting in physical or sexual assault or other criminal activity (e.g., stalking).

  • Reinforce to supervisors and other leaders that harassment by patients and third parties is as serious as harassment from within the organization. Ensure supervisors and other leaders are aware of the organization’s legal and ethical responsibility to protect employees.

  • Educate all employees about the organization’s zero-tolerance policy for all forms of discrimination and harassment. Emphasize the expectation that employees will report harassment they experience or witness immediately.

  • Reinforce employee trust in organizational leaders and processes by following transparent protocols and ensuring all incidents are handled promptly and consistently.

Resources


This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Informed Refusal: A Review

Patient Safety & Risk Solutions

Informed refusal, like informed consent, is a concept that relies on ethical and legal guidelines that acknowledge the right of competent adults to determine the course of their healthcare. Also, like informed consent, informed refusal refers to a process that requires consultation between a healthcare provider and a patient to determine viable treatment options and engage the patient in treatment-related decisions.

As a healthcare provider, effective communication and thorough patient education are your best allies for encouraging patient collaboration and gaining patient cooperation in selecting and adhering to a treatment plan.

However, patients can refuse care even if the consequences might be dire. Patients also have the right to change their minds and withdraw consent for treatment they have previously authorized, even when the treatment has been started.

Risk Considerations

When a patient refuses treatment or wants to abandon a treatment plan, you should consider the following questions:

  • Was the patient given adequate information about his/her diagnosis as well as treatment options that meet the current standard of care?

  • Did you thoroughly discuss with the patient the risks and benefits of treatment options?

  • Did you and the patient discuss and agree upon mutual expectations for a satisfactory outcome?

  • Did you encourage the patient to ask questions and voice concerns? Were these questions and concerns addressed to the patient’s satisfaction?

  • Did you explain the risks associated with refusing treatment? Risks might include:
    • Fewer treatment options as the condition deteriorates.
    • Lower probability of a successful or optimal outcome.
    • Higher probability of complications.
    • Remaining treatment options that are more expensive than the treatment that was initially recommended.

  • Did you ask for the patient’s reason for the decision? If you are aware of the patient’s reason for refusal, you might be able to propose an alternative treatment option that the patient will accept.

These examples illustrate the figurative seesaw that the healthcare community has experienced with EHR technology. As a result, feelings about EHRs often are mixed, and many providers cite EHR issues as a key contributor to clinician burnout.

In addition to clinical and operational issues, EHRs also have introduced a new dynamic in malpractice liability. A survey from the Medical Professional Liability (MPL) Association (formerly PIAA) found that more than half of member companies had EHR-related malpractice litigation.2 Major contributing factors in this litigation included problems with documentation, system functionality, metadata, record format, vendor support, and more. Further, a review of malpractice claims facilitated by CRICO Strategies showed that claims involving EHR factors were costly and almost half resulted in high-severity outcomes (i.e., permanent disability or death).3

This article focuses on a number of areas in which EHR-related risks may occur due to time constraints, inexperience, oversight, system usability, or other factors. Risk strategies also are presented for each area covered, with the hope that they will lay the groundwork for more thorough discussions within healthcare organizations about how to manage risks associated with complex EHR systems.

Documentation

If the patient has received adequate information and education, but still refuses treatment, you should scrupulously document the decision in the patient’s health record. Documentation should include the patient’s diagnosis, the recommended treatment, the outcomes that might occur if the condition isn’t treated, and all patient education efforts.
If you opt to use an informed refusal form, give the patient a copy of the signed form and retain the original in the patient’s health record. The form should include:

  • The patient’s diagnosis

  • Treatment options and the treatment plan the patient elected (if any), as well as risks and benefits associated with each

  • Acknowledgement that the patient refused or terminated treatment

  • Specific risks that might occur if the patient doesn’t receive care, and acceptance of the risk on the part of the patient

  • The patient’s signature (if he/she agrees to sign)

Although it is not always necessary for the patient to sign an informed refusal form, the request forces the patient to acknowledge the seriousness of the untreated condition. Many patients will sign the form, but some refuse. In the event of refusal, you should document that the patient was asked to sign the form and would not do so.

Some providers like to have a witness present when a patient refuses needed care. When an employee has been asked to witness the informed refusal process, he/she should sign the record and date the signature — regardless of whether the patient agrees to sign.

Ongoing Care

By refusing urgently needed care, patients might increase their risk of injuries and possibly increase your liability risk. Under these circumstances, you might (a) continue to see and treat such patients with the hope that they might change their mind or that, if their conditions deteriorate, emergent care can still be initiated, or (b) feel that you have no other choice but to formally withdrawal from these patients’ care.

If you decide to withdraw from a patient’s care because of a treatment refusal, a discussion should take place, if possible, before the formal discharge process occurs. The patient should know that you feels strongly enough about the recommended treatment that you might withdraw rather than stand by as a witness to the deterioration of the patient’s condition.

Having decided to withdraw, you should formalize the notification with a discharge letter, giving the patient adequate time (generally 30 days) to find another practitioner. The letter should be sent to the patient via certified mail with return receipt requested, and an additional copy should be sent through first class mail. Copies of the letter should be maintained in the patient’s file.

For more information, see MedPro’s guideline titled Terminating a Provider–Patient Relationship.

In Summary

When patients refuse necessary care, healthcare providers must be vigilant in ensuring that the patients understand the potential risks and consequences of their decisions. Providers also should make sure all informed refusal processes are thoroughly documented in patients’ health records, including any related forms or documents. When in doubt about how to handle a patient’s refusal of treatment or withdraw from a treatment plan, contact a risk management expert.

This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.

Electronic Health Records: Patient Safety and Liability Concerns

Laura M. Cascella, MA

Health information technology (HIT) has significantly shaped the landscape of modern healthcare. At the forefront of the burgeoning HIT industry are electronic health records (EHRs), which arguably represent the most consequential technological advance for healthcare in recent decades.

EHRs have revolutionized the documentation of patient care. For the majority of healthcare organizations and practitioners, paper records are a relic of the past, replaced by exam room computers and digital interfaces. Virtually all hospitals in the United States use EHRs, and almost 90 percent of office-based physicians have adopted these systems.1 The shift from paper to electronic records has been slower in dentistry, but the number of dental practices implementing EHRs continues to grow.

The promise of EHR capabilities has been ambitious and perhaps borderline utopian — these systems have been lauded as a way to vastly improve patient safety, efficiency, care coordination, and information sharing. However, the reality of EHRs has been a complex intertwining of incremental improvements, risks, and frustrations. Many benefits have been tempered by negative effects or outcomes. For example:

  • Increased access to patient data has resulted in information overload and data dumps.

  • Enhanced clinical decision support and patient alerts can cause alarm fatigue.

  • The convenience of electronic prescribing and referrals has been moderated by system glitches and human factors that result in errors or oversights.

  • The elimination of issues associated with clinician illegibility can be offset if printed electronic records contain coding gibberish or massive amounts of meaningless data.

These examples illustrate the figurative seesaw that the healthcare community has experienced with EHR technology. As a result, feelings about EHRs often are mixed, and many providers cite EHR issues as a key contributor to clinician burnout.

In addition to clinical and operational issues, EHRs also have introduced a new dynamic in malpractice liability. A survey from the Medical Professional Liability (MPL) Association (formerly PIAA) found that more than half of member companies had EHR-related malpractice litigation.2 Major contributing factors in this litigation included problems with documentation, system functionality, metadata, record format, vendor support, and more. Further, a review of malpractice claims facilitated by CRICO Strategies showed that claims involving EHR factors were costly and almost half resulted in high-severity outcomes (i.e., permanent disability or death).3

This article focuses on a number of areas in which EHR-related risks may occur due to time constraints, inexperience, oversight, system usability, or other factors. Risk strategies also are presented for each area covered, with the hope that they will lay the groundwork for more thorough discussions within healthcare organizations about how to manage risks associated with complex EHR systems.

Implementation/Conversion

Moving from paper records to an EHR system or converting from one EHR system to another is inherently risky because data can be lost or misplaced, workflow processes change, and new skills and knowledge must be obtained. Implementation/conversion is a multistep process that should involve identifying organizational needs, performing due diligence of vendors and products, strategic planning, and ongoing assessment and adjustment once the system is in place.

The Office of the National Coordinator for Health Information Technology (ONC) notes that successful implementation requires a two-phase approach: pre-implementation and implementation.4 The first phase focuses heavily on the “big-picture” strategy, including establishing an overall implementation plan, developing governance processes, and designing workflow patterns.

The pre-implementation phase also includes communicating with providers and staff about the new system and the conversion process as well as providing ample training opportunities. Careful evaluation of workflow processes and an open dialogue with staff may help identify potential issues early, so effective strategies can be developed and applied.

The second phase involves more detailed evaluation and adjustment, such as tailoring the system to meet the specific needs of the organization, establishing a change-management process, and determining how to transfer information and reconcile legacy data with data in the new system, so as not to misplace important records or overlook critical health information.

The implementation phase also involves providing overall support for the new system and encouraging adoption of the system among providers and staff. Workforce cooperation and compliance are critical during the implementation phase. For those managing the process, it is important to realize that some providers and staff may welcome the new technology, while others might resist the change.

In some instances, provider/staff resistance has led organizations to maintain both paper and electronic systems to meet everyone’s preferences. However, research has shown that hybrid systems decrease efficiency and increase the risk of errors.5 Although it might be tempting to try to satisfy everyone, it also can be counterproductive and, ultimately, it does not support a culture of safety or environment of cohesive teamwork.

Strategies for Implementation/Conversion

  • Include providers and staff members who will be using the EHR system in initial research and planning activities.

  • For paper-to-electronic conversions, develop a plan for how your organization will handle paper records once the EHR system is implemented. Will paper records be scanned into the new system? Will scanned documents be searchable? What are the expectations for providers to reconcile old records with new ones during patient encounters?

  • For conversions from one EHR system to another, determine the previous vendor’s and new vendor’s roles in information transfer (i.e., contractual obligations and requirements). Does the data need to be optimized prior to conversion? What are the deadlines for data transfer between systems? Will your organization have access to the old system after the conversion, and for how long?

  • Seek provider/staff input on developing policies and workflow processes that align with their needs as well as the functionality of the new system.

  • Support providers and staff throughout the pre-implementation and implementation phases by (a) including them in the decision-making process, (b) maintaining transparent communication; and (c) establishing firm, yet reasonable expectations related to EHR use.

  • Be realistic about the cost (both in external resources and staff time) that it will take to implement the new system.

  • Provide training and education during pre-implementation and implementation — as well as after the system is in use — to help providers and staff acclimate to the EHR’s interface and functionality, recognize potential process or system problems, and work toward achievable solutions.

For in-depth information about implementing an EHR system and valuable tools to assist in the process, see Section 1 of the ONC’s Health IT Playbook and the American Medical Association’s (AMA’s) STEPS Forward Electronic Health Record (EHR) Implementation module.

Documentation

Accurate and thorough documentation is the backbone of risk management; it provides essential patient information, historical details about the course of patient care, and a record of services provided.
EHRs are intended to streamline the documentation process, while at the same time capturing more information than was previously possible with paper records. Although this may result in more substantive patient information, it also presents opportunities for error due to EHR-specific functions, such as copy and paste; structured and standardized content; and metadata and audit trails.

Copy and Paste

The practice of copy and paste is one of the most common and problematic documentation issues associated with EHRs. Both the MPL Association’s and CRICO Strategies’ malpractice analyses cite this practice as a top trend in EHR-related allegations.6

Copy and paste — also called cut and paste, cloning, or carrying forward — refers to electronically lifting information from a previous entry in a patient’s record and placing it in the current entry. It also refers to copying information from one patient record to paste into another, such as through the use of boilerplate language.

Automated functions within EHR systems facilitate the cloning of information because of the ease with which users can grab and move content. Practitioners who feel crunched for time may find the copy and paste function enticing because it’s quick and easy. Although the level of convenience is clear, “Less clear is the line between efficiency and note quality.”7 Copying and pasting content can result in the proliferation of incorrect or non-consequential information throughout electronic records, which can lead to patient harm if treatment decisions are based on erroneous or old information — or if practitioners are so overwhelmed by “note bloat” that they miss critical information.

Copy and paste also can affect healthcare providers’ credibility, both in litigation and with patients. In a special report about copy and paste, ECRI Institute relays the story of a physician who, while talking with a comatose patient’s family, stated that the patient had only recently had surgery (within the previous days). In reality, the patient had undergone surgery more than a month prior, but the phrase “postoperative day 2” had been copied and pasted in the progress notes for weeks.8

Additionally, the use of copy and paste can have serious corporate compliance implications. When information is carried forward from encounter to encounter without careful review by the healthcare provider, the organization might end up billing for services that did not occur. Even though this type of billing error might be a simple oversight, it could lead to allegations of fraud, which may jeopardize reimbursement from Medicare and other payers.

Copy and paste also can have a negative effect on data integrity. One of the broad goals of EHR systems is to facilitate the electronic exchange of health information and collection and submission of clinical quality measures. Inaccurate data that result from poor practices like copying and pasting may have long-term implications for population health studies, disease tracking, and data mining.9

Strategies for Copy and Paste

  • As part of documentation policies, establish guidelines for when copy and paste is prohibited and when it may be used with extreme care.

  • In situations in which copy and paste is allowed, ensure that organizational policy stipulates the need for practitioners to carefully review any information carried forward in records.

  • Reinforce practitioners’ responsibility for updating/revising copied information as appropriate and electronically signing each record to verify their review and approval of the information.

  • Include in documentation policies a requirement that providers note the source of any information they copy and paste in records.

  • Encourage providers to revise copied and pasted material to remove redundancy and extraneous details.

  • Routinely audit records to check for errors that may have resulted from copying and pasting patient information.

  • Educate staff about the dangers and consequences of using poor documentation practices and shortcuts, such as misinformed treatment decisions and fraudulent billing.

To assist healthcare organizations and providers, the Partnership for Health IT Patient Safety released a toolkit for the safe use of copy and paste, which included four core safe practice recommendations: (1) provide a mechanism to make copy and paste material easily identifiable; (2) ensure that the provenance of copy and paste material is readily available; (3) ensure adequate staff training and education regarding the appropriate and safe use of copy and paste; and (4) ensure that copy and paste practices are regularly monitored, measured, and assessed.10

Structured/Standardized Content

One of the purported benefits of EHRs is structure and standardization, which is accomplished through functions such as data entry fields, check boxes, drop-down menus, auto-fill, and templates. When used appropriately, these elements can help generate consistent documentation across providers. However, standardization also presents new dilemmas.

For example, inaccuracies in the records might occur if:

  • The data entry fields don’t match the clinical situation.

  • Patient identification issues cause a provider to enter data in the wrong patient record.

  • The system automatically defaults to a selection of “normal.” If all options are not carefully reviewed, the record might indicate a normal value for a condition that was never evaluated.

  • The auto-fill function populates incorrect information in a field, and the provider accepts the information without review.

  • The provider selects the wrong template, check box, or menu item, which can easily happen when multiple options are presented and time is scarce.

  • The provider is unaware of how taking an action within the EHR ultimately affects the physical output of the record.

Undoubtedly, data entry fields, check boxes, drop-down menus, auto-fill, and templates can create efficiencies, but they also can contribute to the domino effect of replicating inaccurate information. An article about EHR liability in For the Defense explains that “if one provider puts in a wrong medication, a wrong diagnosis, or an incorrect medical history, the systems are typically designed to keep repopulating and disseminating the erroneous information. Keep in mind that one wrong entry might not stay in the system of origin, but it might find it way to a separate pharmacy, specialist, or outside primary care system.”11

Further, overreliance on structured/ standardized content can result in records that lack specificity. Without the unique patient narratives that were customary in paper records, it might be difficult to distinguish one patient encounter from the next, creating uncertainty about critical thinking, clinical reasoning, and diagnostic- and treatment-related decision-making.

Strategies for Structured/Standardized Content

  • Ensure that the EHR product you select can be tailored to the clinical situations that are relevant to your organization.

  • Be aware of whether your system automatically defaults to a normal setting. If so, carefully review the record at each encounter to ensure it doesn’t misrepresent clinical information.

  • Provide a final quality control review of all data you enter and boxes you select in the EHR.

  • Occasionally print out records to ensure information is presented in a logical, accurate format.

  • In addition to using data entry fields, check boxes, drop-down menus, and auto-fill, provide patient-specific notes and comments in the record, as appropriate and necessary.

Metadata and Audit Trails

As mentioned previously, EHRs present an opportunity to collect more data than was ever possible with paper records — and not just data that reside within patient records. A distinguishing characteristic of EHRs is their ability to collect metadata, or “data about data.” The metadata generated by an EHR leave an audit trail that may show information such as:

  • Who accessed a record, when they accessed it, and the machine on which the information was accessed

  • The date and time that test results were reviewed

  • The data and time that a record was modified

  • How long a provider had a record open and how quickly he/she selected various options

  • How a provider responded to system-generated alerts or advisories

Simply stated, metadata and audit trails provide “a permanent electronic footprint”12 that tracks “each access, update, and action performed by each user . . .”13 This information can play a pivotal role in malpractice litigation — either by confirming a healthcare provider’s recollection of events or showing discrepancies in a provider’s statements.

Consider the following scenario: A provider claims to have entered documentation at the point of care, but the EHR audit trail reveals that the majority of documentation was not entered for several weeks. Even if the documentation is accurate, the discrepancy in timing might cast doubt on the provider’s credibility.

For some practitioners, metadata might necessitate a change in workflow. For example, providers who have typically entered some information into patient records prior to the actual patient encounters will need to adjust their processes. Otherwise, metadata might show inconsistencies in the timing of events. Further, providers should be cognizant of following organizational policies related to documentation timeframes and protocols for amending records.

Strategies for Metadata and Audit Trails

  • Learn how your EHR system’s metadata function works, and develop documentation policies around that knowledge.

  • Ensure that providers and staff in your practice are mindful of the type of metadata that the EHR system collects.

  • Adjust workflow processes as necessary to eliminate inconsistencies in metadata.

  • Develop guidance for how to appropriately amend or update electronic records. Without a defined policy, changes to a record may raise questions about the validity and integrity of information.

  • Be aware of your state’s laws or rules related to e-discovery. Consider hiring an outside party to perform an annual audit of your EHR system and provide feedback about the quality of documentation, adherence to regulatory standards, and billing/coding compliance.

Alert Fatigue

Perhaps one of the most powerful patient safety capabilities of EHR systems is their potential to analyze patient data, provide clinical decision support, and send providers auditory or visual safety alerts (e.g., reminders that patients are due for screening tests or notifications about possible contraindications, such as dangerous drug–allergy interactions). These tools are valuable, but only when they are efficiently implemented and used.

Unfortunately, “in the current highly computerized clinical environment, an individual clinician interacts with many different alert-generating devices—meaning that every day, clinicians are on the receiving end of a staggering number of alerts.”14 Systems that bombard providers with an overabundance of alerts can be frustrating and lead to a phenomenon known as “alert fatigue” or “alarm fatigue,” in which providers — pressed for time and exhausted by the sheer number of notifications — ignore or override alerts without verifying their clinical significance.

A survey of primary care providers from the Department of Veterans Affairs showed that almost one-third of those using EHRs reported that they missed or did not follow up on alerts about patient test results, and almost 87 percent thought the quantity of EHR alerts was excessive.15 Another study noted that clinicians ignore safety notifications between 49 percent and 96 percent of the time.16 Although many of these dismissed notifications do not result in patient harm, alert fatigue has contributed to various adverse outcomes and is considered a significant patient safety hazard.17

These study results suggest that when providers are inundated with massive numbers of noncritical or nonrelevant notices, the likelihood that important information will be overlooked increases. After receiving a number of unhelpful alerts, a clinician might bypass the next alert based on the assumption that it is another “false alarm” — when, in fact, it might contain critical information.

To complicate matters, not all alerts that are overridden are the result of providers ignoring the system. Many times, alerts are overridden for valid clinical reasons. However, metadata that capture overrides likely will not distinguish between the two. If metadata are used as evidence in a malpractice lawsuit, a healthcare provider might have to defend why he/she overrode a system alert.

Addressing alert fatigue requires consideration of the human and systems factors that contribute to the issue “as the problem fundamentally arises from both the technology itself and how busy human beings interact with the technology.”18

Strategies for Alert Fatigue

  • Determine whether your EHR system’s alert function can be tailored for your healthcare organization, your overall patient population, and specific patient characteristics (e.g., patients who are at high risk for potential adverse outcomes due to certain diseases or conditions).

  • If your organization is in the process of purchasing an EHR system, include questions about the alert capabilities in your initial research and assessment of products.

  • Ask your vendor whether the system’s alerts can be classified based on severity or other factors, and make sure the different types of alerts are presented in different ways.

  • Limit interruptive alerts to only those that are classified as severe.

  • Determine whether alerts that are clinically nonconsequential can be turned off or minimized to reduce alert burden.

  • Provide documentation and support for overriding clinically significant alerts.

Take-Away Message

EHRs represent the present and future of health record documentation. When used properly and with careful consideration, EHRs offer opportunities to streamline processes, enhance quality of care, and support patient safety efforts.

However, like all types of technology, EHRs aren’t without problems and risks. Changes in workflow, poor system design and usability issues, lack of understanding about these systems and their capabilities, user errors and system errors, and lack of defined protocols can all lead to process breakdowns and errors.

Awareness of the potential risks that EHRs present can help healthcare organizations, providers, and staff proactively address them through ongoing staff training, workflow evaluation, and development of comprehensive policies and procedures.

Endnotes


This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.